COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
FDA 510(k) K242057 · Avanos Medical, Inc.
510(k) numberK242057
Submission
- Device name
- COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- Applicant
- Avanos Medical, Inc.
Alpharetta, GA, US - Received
- July 15, 2024
- Decision date
- August 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…GXD · Traditional | Boston Scientific Neuromodulation Corporation | 08/07/2025SE |
| K232632 | Racz Neurostat RF GeneratorGXD · Traditional | Epimed International | 05/24/2024SE |
| K231675 | OneRF Ablation SystemGXD · Traditional | Neuroone Medical Technologies Corp. | 12/06/2023SE |
| K220122 | Apex 6GXD · Traditional | Rf Innovations, Inc. | 03/15/2023SE |
| K203293 | Abbott Medical Grounding Pad, model RF-DGP-ISGXD · Traditional | Abbott Medical | 01/21/2022SE |
| K201610 | IonicRF GeneratorGXD · Traditional | Abbott Medical | 10/21/2020SE |
| K192491 | Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional | Avanos Medical, Inc. | 02/21/2020SE |
| K181864 | Polaris RF Ablation SystemGXD · Traditional | Baylis Medical Company, Inc. | 01/02/2019SE |
| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | Relievant Medsystems | 08/18/2017SE |
| K170242 | MultiGen 2 RF Generator SystemGXD · Traditional | Stryker Corporation | 05/25/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg…IRP · Special | 01/31/2025SE |
| K241185 | CORGRIP* SR NG/NI Tube Retention SystemKNT · Traditional | 10/25/2024SE |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950)KNT · Traditional | 06/06/2024SE |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS)KNT · Traditional | 04/22/2022SE |
| K203066 | COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional | 12/22/2020SE |
| K192491 | Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional | 02/21/2020SE |
| K191340 | CORTRAK* 2 Equilateral Enteral Access SystemKNT · Special | 06/04/2019SE |
Questions and answers
When was COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) cleared by the FDA?
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) (K242057) received a 510(k) decision of Substantially Equivalent on August 14, 2024, 30 days after the submission was received.
What is the product code of K242057?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.